Faculty of Engineering and Computing

faculty of engineering and computing

common errors with regard to ethics in FP7

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Taken from “The EU gets tough on Ethics” by Mary Fitzgerald – European Commission’s Ethics Review Team. (Full article available here)

Certain common errors appear frequently in proposals. Do take time to address these issues in your information sheets and consent forms - they are not particularly difficult to avoid.

1. Children

The involvement of children is very sensitive. Identify if there is a direct benefit to the individual child. If this individual benefit is not present and children need to be involved in a study, it is necessary to ensure that the procedure carries a minimum risk for the child and a minimum burden is placed on a child.

2. Anonymisation of Data

With regard to Personal Data, do not confuse coding with anonymisation.

3. Insurance

The Commission is concerned about the risks and liability associated with research, particularly clinical trials. Mention the broad details of your insurance coverage.

4. Incidental Findings

‘Incidental findings’ refer to the medical problems discovered in the course of a research/clinical trial which were not related to the topic of research. It is necessary to declare how you will deal with such findings. There is no right or wrong answer; different research groups have different approaches. It is imperative that the research subject is made aware of the approach being taken.

5. Conflict of Interest

Avoid situations that could be construed as giving rise to a conflict of interest – for instance, a treating physician who is involved in a research activity should not be the person to inform the subject about the pros and cons of the clinical trial.

6. Incentives

You must fully disclose incentives. Financial incentives are the most common but others exist; in a developing country money may not be the most common incentive. No definitive answers exist - the right approach depends on the context. You must also confirm to the subjects that leaving the study will not have adverse consequences.

7. Use of Animals

Numbers, species and origin of animals need to be specified. Identify what happens at the end of the research project. It could be embarrassing to assert that no alternatives were available to your animal work without checking relevant databases.